Containers for reading and handling diagnostic reagents and methods of using the same

ABSTRACT

A container with a rotatable lid for reading and handling diagnostic reagents in tape form comprising a body portion, a lid portion, a continuous tape, a reagent-sensing device, and a storage device. The body portion includes an inner and outer surface. The lid portion is attached to the body portion and is adapted to rotate from a closed position to an open position. The continuous tape includes a diagnostic reagent. The reagent-sensing device is attached to either the body portion or the lid portion and adapted to read the diagnostic reagent. The storage device is attached to the body portion that is adapted to hold and dispense an unused portion of the continuous tape. During the rotation of the lid portion, the continuous tape is advanced from the first storage device and is extended over the reagent-sensing device.

RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.10/845,335, entitled “Containers For Reading And Handling DiagnosticReagents And Methods For Using The Same,” which was filed on May 14,2004, and which claims the benefit of U.S. Provisional Application Ser.No. 60/479,170 filed on Jun. 18, 2003, both of which are herebyincorporated by reference herein in their entirety.

FIELD OF THE INVENTION

The present invention relates to containers for reading and handlingdiagnostic reagents and methods of using the same. More specifically,the present invention relates to containers that use tape that includesdiagnostic reagents, and methods of using the same.

BACKGROUND OF THE INVENTION

The quantitative determination of analytes in body fluids is of greatimportance in the diagnoses and maintenance of certain physiologicalabnormalities. For example, lactate, fructosamine, cholesterol,bilirubin, alcohol, and drugs may be monitored or tested in certainindividuals. The monitored or tested body fluids may include blood,interstitial fluid, saliva, or urine. In particular, determining glucosein body fluids is important to diabetic individuals who must frequentlycheck the glucose level in their body fluids to regulate the glucoseintake in their diets.

There have been existing containers that have included reagents in tapeform. These containers, however, have one or more disadvantages. Forexample, one disadvantage of existing containers is that the testsensors must be delivered from the container. In such containers, theused sensors are not stored in the container and, thus, may not allowfor a convenient and/or safe disposal. Other disadvantages of existingcontainers include not (a) adequately providing protection againstenvironmental moisture that degrades the reagent and/or (b) keeping thereagent-sensing device adequately clean and protecting it from wear andtear of normal usage.

It would be desirable to provide a container that detects an analyteconcentration such as glucose that overcomes the above-notedshortcomings.

SUMMARY OF THE INVENTION

According to one embodiment, a container with a rotatable lid forreading and handling diagnostic reagents in tape form comprises a bodyportion, a lid portion, a continuous tape, a reagent-sensing device, anda storage device. The body portion includes an inner and outer surface.The lid portion is attached to the body portion and is adapted to rotatefrom a closed position to an open position. The continuous tape includesa diagnostic reagent. The reagent-sensing device is attached to eitherthe body portion or the lid portion and adapted to read the diagnosticreagent. The storage device is attached to the body portion that isadapted to hold and dispense an unused portion of the continuous tape.During the rotation of the lid portion, the continuous tape is advancedfrom the first storage device and is extended over the reagent-sensingdevice.

According to another embodiment, a container with a rotatable lid forreading and handling diagnostic reagents in tape form comprises a bodyportion, a lid portion, a continuous tape, a reagent-sensing device, afirst storage device, and a second storage device. The body portionincludes an inner and outer surface. The lid portion is attached to thebody portion and is adapted to rotate from a closed position to an openposition. The continuous tape includes a diagnostic reagent. Thereagent-sensing device is attached to either the body portion or the lidportion and adapted to read the diagnostic reagent. The first storagedevice is attached to the body portion that is adapted to hold anddispense an unused portion of the continuous tape. The second storagedevice is attached to the lid portion that is adapted to receive a usedportion of the continuous tape. During the rotation of the lid portion,the continuous tape is advanced from the first storage device and isextended over the reagent-sensing device and received by the secondstorage device.

According to a further embodiment, a container with a rotatable lid forreading and handling diagnostic reagents adapted to determine glucoseconcentration in tape form comprises a body portion, a lid portion, acontinuous tape, a reagent-sensing device, and a first storage device.The body portion includes an inner and outer surface. The lid portion isattached to the body portion and is adapted to rotate from a closedposition to an open position. The continuous tape includes a diagnosticreagent to determine glucose concentration. The reagent-sensing deviceis attached to either the body portion or the lid portion and adapted toread the diagnostic reagent. The first storage device is attached to thebody portion that is adapted to hold and dispense an unused portion ofthe continuous tape. During the rotation of the lid portion, thecontinuous tape is advanced from the first storage device and isextended over the reagent-sensing device.

According to one method, a container with a rotatable lid for readingand handling diagnostic reagents in tape form comprises providing arotatable container. The rotatable container comprises a body portion, alid portion, a continuous tape, a reagent-sensing device and a firststorage device. The body portion includes an inner and outer surface.The lid portion is attached to the body portion. The continuous tapeincludes a diagnostic reagent. The reagent-sensing device is attached toeither the body portion or the lid portion and adapted to read thediagnostic reagent. The first storage device is attached to the bodyportion and is adapted to hold and dispense an unused portion of thecontinuous tape. The lid is rotated from a closed position to an openposition. The continuous tape is advanced from the first storage deviceto extend over the reagent-sensing device during the rotation of the lidportion.

BRIEF DESCRIPTION OF THE DRAWINGS

Other advantages of the invention will become apparent upon reading thefollowing detailed description and upon reference to the drawings inwhich:

FIG. 1 is a rotatable container shown in a closed position according toone embodiment of the present invention;

FIG. 2 is the rotatable container of FIG. 1 shown in an open position;

FIG. 3 is a rotatable container shown in a closed position according toanother embodiment of the present invention; and

FIG. 4 is the rotatable container of FIG. 3 shown in an open position.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Itshould be understood, however, that it is not intended to limit theinvention to the particular forms disclosed but, on the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the invention as defined by theappended claims.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

The present invention is directed to containers for reading and handlingdiagnostic reagents in tape form and methods of using the same. Thediagnostic reagents may be independently selected to test one or moreanalytes such as glucose, lactate, fructosamine, cholesterol, bilirubin,alcohol and/or drugs. It is contemplated that other analytes may betested using the containers of the present invention. The body fluids tobe tested may include blood, interstitial fluid, saliva, or urine. It iscontemplated that other fluids may be tested using the containers of thepresent invention. One commonly tested analyte is glucose in a wholeblood sample.

The containers of the present invention comprise a body portion, a lidportion, a continuous tape, a reagent-sensing device, and a firststorage device that is adapted to hold and dispense an unused portion ofthe continuous tape. The rotatable container provides protection againstenvironmental moisture that degrades the reagent and keeps thereagent-sensing device clean and protects it from wear and tear ofnormal usage. The lid portion is adapted to rotate from a closedposition to an open position where the rotation advances the continuoustape.

Referring to FIGS. 1 and 2, a rotatable container 10 is depicted in aclosed position (FIG. 1) and an open position (FIG. 2). The rotatablecontainer 10 is adapted to read and handle diagnostic reagents in tapeform. The rotatable container 10 comprises a body portion 12, a lidportion 14, a continuous tape 16, and a reagent-sensing device 18. Thelid portion 14 is adapted to rotate from a closed position to an openposition as shown in FIGS. 1 and 2. The rotatable container may berotated from the open position to the closed position via hinge 30. Thehinge may be made of metal or may be a living hinge. Living hinges aretypically made of polymeric materials that are flexible such aspolypropylenes or polyethylenes. It is contemplated that the rotatablecontainer may be moved from the open position to the closed positionusing other methods.

Continuous Tape

The continuous tape 16 includes a diagnostic reagent and is stored on afirst storage device 20 in FIGS. 1 and 2. The first storage device 20may be a spool or reel that is generally circular such as shown in FIGS.1 and 2. Alternatively, the first storage device may be a polygonalshape such as a rectangle or a non-polygonal shape that is adapted tohold and dispense the continuous tape 16. It would be desirable to havea first storage device that is adapted to hold and dispense a Z-foldedcontinuous tape. The first storage device 20 is shown attached to thebody portion 12 and is adapted to hold and dispense an unused portion ofthe continuous tape 16. As shown in FIG. 2, the continuous tape 16includes an unused portion 16 a and a used or spent portion 16 b. Duringthe rotation of the lid portion 14 from the body portion 12, thecontinuous tape 16 is advanced from the first storage device 20. Thecontinuous tape 16 is extended or pulled over the reagent-sensing device18. The advancing of the continuous tape 16 places the unused reagent inthe correct position against the reagent-sensing device 18. Thus, theopening of the lid portion 14 from the body portion 12 accomplishes (a)exposing the reagent-sensing device 18, (b) advancing the continuoustape 16 to a fresh or unused reagent area, and (c) stretching thecontinuous tape 16 with the reagent over the reagent-sensing device 18.When the lid portion 14 is placed in a closed position, the continuoustape 16 moves away from the reagent-sensing device 18 as shown in, forexample, FIG. 1.

The continuous tape 16 may include one or more reagents to assist indetermining the concentration of the amount of a fluid sample. Thediagnostic reagent may be disposed in or on the continuous tape. Forexample, in one embodiment, the diagnostic reagent is disposed onmembranes adhered to the continuous tape. The diagnostic reagent may behumidity sensitive. To determine glucose in a whole blood sample, forexample, the reagent may be an enzyme such as glucose oxidase. Oneexample of a reagent may be found in the Glucometer ENCORE® made byBayer Corporation. Another glucose indicator reagent that may be used isglucose dehydrogenase, NAD, diaphorase, tetrazolium indicator (WST-4),and polymers. Other non-limiting examples of reagents may be used in thecontinuous tape. The continuous tape 16 may be made of polymericmaterials, including polyethylene terephthalate (PET), polycarbonate orpolystyrene. An example of a reagent on tape is one used in the CLINITEKATLAS® automated urine chemistry analyzer made by Bayer Corporation.

According to one embodiment, the reagent is a part of the continuoustape and, thus, remains attached to the continuous tape throughout theprocess. According to another embodiment, the reagent may be laminatedto the continuous tape such that the reagent is adapted to separate fromthe continuous tape. In such an embodiment, the continuous tape may bereferred to as a carrier.

According to one embodiment, the rotatable container 10 furthercomprises a second storage device 22. The second storage device 22 maybe, for example, a spool or other type of storage device adapted toreceive the used or spent continuous tape. As shown in FIGS. 1 and 2,the second storage device 22 is attached to the lid portion 14. Thesecond storage device 22 may be desirable because it provides aconvenient and safe disposal for the used or spent portion of thecontinuous tape 16. In such an embodiment, it is desirable for the usedreagent to remain on the continuous tape 16. For example, when the lidportion 14 is placed in a closed position, the used portion of thecontinuous tape (i.e., the portion with used or spent reagent) is placedin or on the second storage device 22.

Reagent-Sensing Device

The reagent-sensing device of the present invention is adapted to readthe diagnostic reagent. The reagent-sensing device also transmits theinformation (e.g., glucose concentration) to the test subject.

Referring to FIGS. 1 and 2, the reagent-sensing device 18 is attached tothe body portion 12. The reagent-sensing device 18 is shown as beingattached to an inner surface of the body portion 12, but it iscontemplated that the reagent-sensing device may be attached to an outersurface of the body portion. For example, the reagent-sensing device maybe attached near or at a top outer surface edge of the body portion(i.e., the edge of the body portion closest to the lid when the lid isin a closed position). It is often desirable to locate thereagent-sensing device within the body portion 12 because it assists inkeeping the reagent-sensing device clean as well as preventing orinhibiting additional wear and tear through normal usage. Thereagent-sensing device 18 is protected from such conditions when the lidportion 14 is in a closed position.

According to one embodiment of the present invention, thereagent-sensing device comprises a test sensor such as anelectrochemical biosensor or an optical biosensor as are known in theart. An electrochemical biosensor uses the reagent from the continuoustape that is designed to react with an analyte in the test fluid tocreate an oxidation current at electrodes disposed within theelectrochemical biosensor. That current is directly proportional to theconcentration of the analyte in the test fluid.

Examples of an electrochemical biosensor that can be used to measureglucose concentrations are those used in Bayer Corporation's GlucometerDEX® and ELITE® systems. The reagent-sensing device of theseelectrochemical sensors may be integrated into the body portion and thelid portion of the containers of the present invention. Electrochemicalbiosensors that may be used in connection with the containers of thepresent invention are described in U.S. Pat. Nos. 5,120,420, 5,660,791,5,759,364, and 5,798,031, each of which is incorporated herein in itsentirety. Another example of an electrochemical sensor is described inU.S. Patent Application Publication No. 2001/0042683, published on Nov.22, 2001, which is incorporated by reference in its entirety. One ormore of the electrochemical sensors may be purchased from MatsushitaElectric Industrial Company. A further example of an electrochemicalsensor that may be used is disclosed in U.S. Pat. No 5,429,735, which isincorporated by reference in its entirety. It is contemplated that otherelectrochemical biosensors may be used in the present invention.

An optical biosensor uses a reagent from the continuous tape and isdesigned to produce a colorimetric reaction indicative of theconcentration of the analyte in the test fluid. The colorimetricreaction is then read by a spectrophotometer incorporated into a testinginstrument. An optical biosensor that may be used in connection isdescribed in U.S. Pat. No. 5,194,393, which is incorporated herein byreference in its entirety. Another example of an optical detectiondevice is described in U.S. Pat. No. 6,096,269, which is incorporatedherein by reference in its entirety.

It is contemplated that a lancet for drawing test fluid such as bloodmay be integrated or coordinated with the biosensor. In one embodiment,the lancet is located on the interior of the body portion. It iscontemplated that the lancet may be placed in other locations.Alternatively, a physically separated lancing device may be used.

The containers of the present invention may include a standard thatcalibrates and checks on the performance of the optical biosensor in thereagent-sensing device. The standard, if used in the rotatable container10, may be mounted on the inside of the lid such that it is properlypositioned in front of the reagent-sensing device 18 and protected fromthe environment. For example, in FIG. 2, a calibration standard 24 isshown as being attached to the lid portion. One example of a calibrationstandard material, is available from Edmund Industrial Optics ofBarrington, N.J. and is referred to as “white reflectance standard.”

It is contemplated that additional items or devices may be locatedwithin the body portion 12. For example, to assist in maintaining a lowhumidity, a desiccant may be added within the body portion 12. A lowhumidity environment is desirable to protect at least the continuoustape with reagent. Non-limiting examples of suitable desiccants that maybe used are a molecular sieve and silica gel. One type of desiccantmaterial that may be used is 13X synthetic molecular sieves fromMultisorb Technologies Inc. of Buffalo, N.Y., available in powder,pellet, and bead forms. Another desiccant that may be used is type 4Asynthetic molecular sieves available from Multisorb Technologies Inc. ofBuffalo, N.Y. or Texas Technologies Inc. of Leander, Tex. It iscontemplated that other desiccants known in the art may be used in thepresent invention.

To assist in preventing or inhibiting moisture vapor ingress, at leastone seal may be attached to either body portion 12 or the lid portion 14such that the seal is located between the body portion 12 and the lidportion 14 when the lid portion is in a closed position. The seal may beattached by, for example, an adhesive or thermal welding or it may be apart of the body portion or the lid portion. The seal may be deformedwhen the lid portion 14 is in a closed position. The seal geometry maybe optimized to minimize water vapor transmission by extending thelength of the diffusion path. It is desirable for the seal to avoidaccommodating a continuous tape sliding therethrough because of thepotential for leaks to occur at such a location. Seals may be made froma variety of materials including, but not limited to, polymericmaterials. Some desirable attributes of a material for forming the sealare high barrier properties (e.g., those with low moisture vaportransmission rates), lubricity for easy opening and closing, andelasticity for allowing the mating surfaces to conform. One non-limitingexample of a polymeric material is a polyolefin such as polypropylene.The seal may be made from other materials such as elastomeric materials.Some materials for forming the seal may include cellular rubber, styreneelastomers, polyolefin elastomers, polyamide elastomers, polyesterelastomers, polyurethane elastomers, and combinations thereof.

According to another embodiment, a rotatable container 110 is depictedin a closed position (FIG. 3) and an open position (FIG. 4). Therotatable container 110 is adapted to read and handle diagnosticreagents in tape form. The rotatable container 110 comprises a bodyportion 112, a lid portion 114, a continuous tape 116, and areagent-sensing device 118. The continuous tape 116 may be the same asdescribed above with respect to the continuous tape 16. Similarly, thereagent-sensing device 118 may be the same as described above with thereagent-sensing device 18 except with its location on the rotatablecontainer. In this embodiment, the reagent-sensing device 118 ismoveably attached between the lid portion 114 and the body portion 112.In the closed position, the reagent-sensing device 118 is adjacent to aninner surface of the lid portion such that the reagent-sensing device118 remains clean and protected from conditions such as dust and dirt.It is contemplated that the reagent-sensing device may be attached atother locations.

The rotatable container 110 further comprises a first storage device 120and a second storage device 122. The lid portion 114 is adapted torotate from a closed position to an open position as shown in FIGS. 3and 4. The rotatable container may be rotated from the open position tothe closed position via hinge 130 or a living hinge. The hinge 130according to one embodiment is attached to the body portion 112 via ahinge support bracket 132. It is contemplated that the rotatablecontainer may be moved from the open position to the closed positionusing other methods.

Referring still to FIGS. 3 and 4, the reagent-sensing device 118 islocated external to the body portion 112 and is attached to the lidportion 114. One advantage of the rotatable container 110 is that thelocation of the reagent-sensing device 118 allows additional space tointegrate the lancet, if used, with the reagent-sensing device 118. Thereagent-sensing device 118 may be moved forward (i.e., upwardly in FIGS.3 and 4) by a mechanism such a rack and pinion drive 128 or a cammechanism that, for example, is operated by a hinge. The first positionof the reagent-sensing device 118 (see FIG. 3) is at approximately thesame height as the top edge 112 a of the body portion 112. The secondposition of the reagent-sensing device 118 (see FIG. 4) is above the topedge of the body portion 112 by a height H1. The height H1 may vary butis generally from about 0.2 to about 0.4 inches. It is desirable to havethe reagent-sensing device extend at least about 0.2 inches above thetop edge 112 a so as to assist the test subject in placing the testfluid on the continuous tape 116. Additionally, such a height may alsoassist placing the continuous tape against the reagent-sensing devicesuch that the continuous tape is flat against the reagent-sensingdevice.

As discussed above, the rotatable container 110 may further include astandard to calibrate and check on the performance of the opticalbiosensor, if used, of the reagent-sensing device. The rotatablecontainer 110 may also include a desiccant and seals.

The base portion and the lid portion of the rotatable containers may bemade of materials having very low water vapor transmission rates. Someexamples of such materials are polymeric materials including, but notlimited to, polyethylene, polypropylene or metals such as aluminum.Additionally, it is contemplated that the individual properties of thebase portion, the lid portion and seal are desirably optimized and donot have to be made of the same materials. It is desirable that the baseportion and the lid portion in the closed position form a sealedcontainer adapted to store humidity-sensitive diagnostic reagents.

METHODS OF THE PRESENT INVENTION

The methods for determining the analyte concentrations (e.g., glucoseconcentrations) may be performed by the test subjects, especially thosewho are diabetic. It is also contemplated that the methods may beperformed by hospital or clinic personnel.

According to one method, the lid portion is rotated with respect to thebody portion to an open position by the test subject. During therotation of the lid portion from the body portion, (a) thereagent-sensing device is exposed, (b) the continuous tape is advancedto a fresh or unused reagent area, and (c) the continuous tape ispositioned with the fresh or unused reagent over the reagent-sensingdevice. The fluid sample (e.g., a whole blood sample) is placed incontact with the unused portion continuous tape that includes a reagentand is located over the reagent-sensing device. The whole blood samplemay be generated by a lancing device such as Bayer's MICROLET®adjustable lancing device. The lancing device may obtain blood by, e.g.,pricking a person's finger. It is desirable to use a low volume of bloodsuch as less than 1 μl. The reagent-sensing device determines theconcentration of the analyte in the fluid sample (e.g., glucoseconcentration) and returns this information to the test subject. It isdesirable to return this information to the test subject in a short timeframe such as from about 5 to about 15 seconds.

To protect the reagent of the unused portion of the continuous tape andthe reagent-sensing device, the lid portion of the container is closedby the test subject upon completion of the testing. During the closingof the lid portion, (a) the continuous tape is moved away from thereagent-sensing device and (b) the reagent-sensing device is protected.Additionally, during the closing of the lid portion, the body portion isdesirably sealed to prevent or inhibit moisture vapor transmission fromentering thereto. It is also contemplated that if a second storagedevice is included in the rotatable container, then the closing of thelid portion may advance or wind the used portion of the continuous tapeonto or in the second storage device.

In another method, the rotation of the lid portion from the body portionto the open position may move the reagent-sensing device forward to alocation above the top edge of the body portion. Such a movement assiststhe test subject in placing the test fluid on the unused portion of thecontinuous tape over the reagent-sensing device.

While particular embodiments and applications of the present inventionhave been illustrated and described, it is to be understood that theinvention is not limited to the precise construction and compositionsdisclosed herein and that various modifications, changes and variationsmay be apparent from the foregoing descriptions without departing fromthe spirit and scope of the invention as defined in the appended claims.

1-10. (canceled)
 11. A sensor system for determining a glucoseconcentration of a fluid sample, the sensor system comprising: anoptical reagent-sensing device; and a container including first andsecond storage devices, at least one of the first or second storagedevices being a rotatable spool, the container further including acontinuous tape comprising a diagnostic reagent and a polymericmaterial, the continuous tape extending from the first storage device,past the optical reagent-sensing device, to the second storage devicesuch that the first storage device holds and dispenses unused portionsof the continuous tape and the second storage device holds and receivesused portions of the continuous tape, the container further including awhite-reflectance calibration standard, the calibration standardoperative to calibrate the optical reagent-sensing device, wherein theoptical reagent-sensing device is operative to read the diagnosticreagent and determine a glucose concentration in less than about 15seconds for a fluid sample having a volume of less than 1 microliter.12. The sensor system of claim 11, wherein the white-reflectancecalibration standard is located within the container.
 13. The sensorsystem of claim 11, wherein the container further includes at least oneseal to assist in limiting moisture from entering into the container.14. The sensor system of claim 11, wherein the diagnostic reagent isdisposed on the continuous tape.
 15. The sensor system of claim 11,wherein the continuous tape further comprises a plurality of membranesattached thereto, the diagnostic reagent being disposed on the pluralityof membranes.
 16. The sensor system of claim 11, wherein diagnosticreagent is disposed in the continuous tape.
 17. The sensor system ofclaim 11, wherein the continuous tape is flat against at least a portionof the optical reagent-sensing device.
 18. The sensor system of claim11, wherein the optical reagent-sensing device is at least partiallydisposed within the container.
 19. The sensor system of claim 11,further comprising a lancet.
 20. A method for determining a glucoseconcentration of a fluid sample with a sensor system, the methodcomprising the acts of: providing an optical reagent-sensing device;providing a container including a first storage device, a second storagedevice, a continuous polymeric tape, a diagnostic reagent, and awhite-reflectance calibration standard operative for calibrating theoptical reagent-sensing device, at least one of the first storage deviceor the second storage device being a rotatable spool, the continuoustape including a first unused segment on the first storage device, asecond segment between the first storage device and second storagedevice that extends over the optical reagent-sensing device, and a thirdused segment on the second storage device, the second segment being atleast partially exposed outside of the container; placing the fluidsample on the exposed second segment of the continuous tape; anddetermining the glucose concentration of the fluid sample in less thanabout 15 seconds using the diagnostic reagent and the opticalreagent-sensing device, the fluid sample having a volume of less than 1microliter.
 21. The method of claim 20, wherein the white-reflectancecalibration standard is located within the container.
 22. The method ofclaim 20, wherein the container further includes at least one sealoperative to limit moisture from entering into the container.
 23. Themethod of claim 20, wherein the diagnostic reagent is disposed on thecontinuous tape.
 24. The method of claim 20, wherein the continuous tapefurther includes a plurality of membranes attached thereto, thediagnostic reagent being disposed on the plurality of membranes.
 25. Themethod of claim 20, wherein the diagnostic reagent is disposed in thecontinuous tape.
 26. A sensor system for determining a glucoseconcentration of a fluid sample, the sensor system comprising: anoptical reagent-sensing device; and a container including a firststorage device, a second storage device, a continuous polymeric tapepartially exposed to an exterior of the container, and a diagnosticreagent, at least one of the first storage device or the second storagedevice being a rotatable spool, the first storage device operative tohold and dispense unused portions of the continuous tape and the secondstorage device operative to hold and receive used portions of thecontinuous tape, the container further including desiccant and awhite-reflectance calibration standard, the calibration standardoperative to calibrate the optical reagent-sensing device, wherein theoptical reagent-sensing device is operative to read the diagnosticreagent to determine a glucose concentration of a fluid sample receivedvia the continuous tape, the fluid sample having a volume of less than 1microliter.
 27. The sensor system of claim 26, wherein the calibrationstandard is located within the container.
 28. The sensor system of claim26, wherein the container further includes at least one seal to assistin limiting moisture from entering into the container.
 29. The sensorsystem of claim 26, wherein the diagnostic reagent is disposed on thecontinuous tape.
 30. The sensor system of claim 26, wherein thecontinuous tape further includes a plurality of membranes attachedthereto, the diagnostic reagent being disposed on the plurality ofmembranes.
 31. The sensor system of claim 26, wherein the diagnosticreagent is disposed in the continuous tape.
 32. The sensor system ofclaim 26, wherein the continuous tape is flat against at least a portionof the optical reagent-sensing device.
 33. The sensor system of claim26, wherein the optical reagent-sensing device is at least partiallydisposed within the container.
 34. The sensor system of claim 26,further comprising a lancet.
 35. A method for determining a glucoseconcentration of a fluid sample with a sensor system, the methodcomprising the acts of: providing an optical reagent-sensing device;providing a container including a first storage device, a second storagedevice, a continuous polymeric tape, a diagnostic reagent, and awhite-reflectance calibration standard, at least one of the firststorage device or the second storage device being a rotatable spool;storing unused portions of the continuous tape via the first storagedevice; storing used portions of the continuous tape via the secondstorage device; calibrating the optical reagent-sensing device using thewhite-reflectance calibration standard; in response to calibrating theoptical reagent-sensing device, rotating the rotatable spool to advancethe continuous tape from the first storage device to the second storagedevice; determining the glucose concentration of the fluid sample inless than 15 seconds using optical reagent-sensing device to read thediagnostic reagent, the fluid sample having a volume of less than 1microliter.
 36. The method of claim 35, wherein the opticalreagent-sensing device is calibrated before determining the glucoseconcentration.
 37. The method of claim 35, wherein the calibrationstandard is located within the container.
 38. The method of claim 35,wherein the continuous tape further includes a plurality of membranesattached thereto, the diagnostic reagent being disposed on the pluralityof membranes.
 39. The method of claim 35, wherein the continuous tape isflat against at least a portion of the optical reagent-sensing device.40. A sensor system for determining a glucose concentration of a fluidsample, the sensor system comprising: an optical reagent-sensing device;and a container comprising a first storage device, a second storagedevice, at least one of the first storage device or the second storagedevice including a rotatable spool, a continuous polymeric tape, thecontinuous tape including a first unused segment on the first storagedevice, a second segment between the first storage device and secondstorage device, and a third used segment on the second storage device,the second segment of the continuous tape being at least partiallypositioned in front of the optical reagent-sensing device and at leastpartially exposed to the exterior of the container, a diagnosticreagent, and a white-reflectance calibration standard operative forcalibrating the optical reagent-sensing device, the rotatable spoolbeing operative to advance the continuous tape after the opticalreagent-sensing device is calibrated, wherein the opticalreagent-sensing device is operative to read the diagnostic reagent todetermine a glucose concentration of a fluid sample having a volume ofless than 1 microliter.
 41. The sensor system of claim 40, wherein theoptical reagent-sensing device is further operative to read thediagnostic reagent and determine the glucose concentration of the fluidsample in less than 15 seconds.
 42. The sensor system of claim 40,wherein the optical reagent-sensing device is calibrated before readingthe diagnostic reagent.
 43. The sensor system of claim 40, wherein thecalibration standard is located within the container.
 44. The sensorsystem of claim 40, wherein the container further includes at least oneseal to assist in limiting moisture from entering into the container.45. The sensor system of claim 40, wherein the diagnostic reagent isdisposed on the continuous tape.
 46. The sensor system of claim 40,wherein the continuous tape further includes a plurality of membranesattached thereto, the diagnostic reagent being disposed on the pluralityof membranes.
 47. The sensor system of claim 40, wherein diagnosticreagent is disposed in the continuous tape.
 48. The sensor system ofclaim 40, wherein the continuous tape is flat against at least a portionof the optical reagent-sensing device.
 49. The sensor system of claim40, wherein the optical reagent-sensing device is at least partiallydisposed within the container.
 50. The sensor system of claim 40,further comprising a lancet.